BR112015004244A2 - orally administered medical composition - Google Patents

orally administered medical composition

Info

Publication number
BR112015004244A2
BR112015004244A2 BR112015004244A BR112015004244A BR112015004244A2 BR 112015004244 A2 BR112015004244 A2 BR 112015004244A2 BR 112015004244 A BR112015004244 A BR 112015004244A BR 112015004244 A BR112015004244 A BR 112015004244A BR 112015004244 A2 BR112015004244 A2 BR 112015004244A2
Authority
BR
Brazil
Prior art keywords
release portion
pharmaceutically acceptable
acceptable salt
formulation
immediate release
Prior art date
Application number
BR112015004244A
Other languages
Portuguese (pt)
Inventor
Toyota Hiroyasu
Hakomori Tadashi
Tsutsui Yuuki
Original Assignee
Astellas Pharma Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Astellas Pharma Inc filed Critical Astellas Pharma Inc
Publication of BR112015004244A2 publication Critical patent/BR112015004244A2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

resumo “composição médica oralmente administrada”. a fim de prover o campo médico com uma formulação única compreendendo uma porção de liberação modificada contendo mirabegron ou um sal farmaceuticamente aceitável do mesmo e uma porção de liberação imediata contendo solifenacina ou um sal farmaceuticamente aceitável do mesmo, (1) uma formulação única tendo taxas de dissolução de ambas as drogas similares àquelas das formulações de droga únicas atuais é provida, e (2) uma formulação única tendo porcentagens máximas de dissolução de ambas as drogas de 90% ou mais, e tendo a biodisponibilidade equivalente àquela das formulações de droga únicas atuais. além disso, a fim de prover uma formulação única, (3) uma formulação única tendo boa produtividade pelo que falhas na produção de comprimidos são reduzidas, e tendo boa estabilidade de armazenamento pelo que a coloração da porção de liberação imediata é suprimida, é provida. a composição farmacêutica para administração oral da presente invenção contém (1) uma porção de liberação modificada compreendendo mirabegron ou um sal farmaceuticamente aceitável do mesmo, e (2) uma porção de liberação imediata compreendendo solifenacina ou um sal farmaceuticamente aceitável do mesmo, e estearato de cálcio.abstract orally administered medical composition. in order to provide the medical field with a single formulation comprising a modified release portion containing mirabegron or a pharmaceutically acceptable salt thereof and an immediate release portion containing solifenacin or a pharmaceutically acceptable salt thereof, (1) a single formulation having rates dissolution rates of both drugs similar to those of current single drug formulations is provided, and (2) a single formulation having maximum dissolution percentages of both drugs of 90% or greater, and having bioavailability equivalent to that of single drug formulations current. furthermore, in order to provide a unique formulation, (3) a unique formulation having good productivity whereby failures in tablet production are reduced, and having good storage stability whereby the coloring of the immediate release portion is suppressed, is provided . The pharmaceutical composition for oral administration of the present invention contains (1) a modified release portion comprising mirabegron or a pharmaceutically acceptable salt thereof, and (2) an immediate release portion comprising solifenacin or a pharmaceutically acceptable salt thereof, and sodium stearate. calcium.

BR112015004244A 2012-08-31 2013-08-30 orally administered medical composition BR112015004244A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012191833 2012-08-31
PCT/JP2013/073351 WO2014034860A1 (en) 2012-08-31 2013-08-30 Orally administered medical composition

Publications (1)

Publication Number Publication Date
BR112015004244A2 true BR112015004244A2 (en) 2017-07-04

Family

ID=50183665

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015004244A BR112015004244A2 (en) 2012-08-31 2013-08-30 orally administered medical composition

Country Status (17)

Country Link
US (1) US20150306090A1 (en)
EP (1) EP2891493A4 (en)
JP (1) JPWO2014034860A1 (en)
KR (1) KR20150045500A (en)
CN (1) CN104602693A (en)
AU (1) AU2013309922A1 (en)
BR (1) BR112015004244A2 (en)
CA (1) CA2883270A1 (en)
EA (1) EA201590449A1 (en)
HK (1) HK1208801A1 (en)
IL (1) IL237423A0 (en)
MX (1) MX2015002633A (en)
PH (1) PH12015500313A1 (en)
SG (1) SG11201501415RA (en)
TW (1) TW201424772A (en)
WO (1) WO2014034860A1 (en)
ZA (1) ZA201501977B (en)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9907767B2 (en) 2010-08-03 2018-03-06 Velicept Therapeutics, Inc. Pharmaceutical compositions and the treatment of overactive bladder
JP2017078023A (en) * 2014-02-28 2017-04-27 アステラス製薬株式会社 Pharmaceutical composition for oral administration
US9956194B2 (en) 2014-12-03 2018-05-01 Velicept Therapeutics, Inc. Compositions and methods of using modified release solabegron for lower urinary tract symptoms
PT3365321T (en) 2015-10-23 2024-01-12 B3Ar Therapeutics Inc Solabegron zwitterion and uses thereof
US20190307696A1 (en) 2016-04-25 2019-10-10 Synthon B.V. Tablets comprising mirabegron and solifenacin
WO2017186598A1 (en) * 2016-04-25 2017-11-02 Synthon B.V. Modified release tablet composition comprising mirabegron
CN107397733B (en) * 2016-05-20 2020-02-07 山东威智百科药业有限公司 Mirabegron sustained release tablet and preparation method thereof
US20170348288A1 (en) * 2016-06-03 2017-12-07 Velicept Therapeutics, Inc. Dosing regimens for beta-3 adrenoceptor agonists and anti-muscarinic agents for the treatment and prevention of lower urinary tract symptoms and overactive bladder
CN106361715A (en) * 2016-09-02 2017-02-01 迪沙药业集团有限公司 Mirabegron composition
KR102051132B1 (en) * 2017-03-17 2019-12-02 주식회사 종근당 Pharmaceutical composition for controlled release comprising Mirabegron or its salts
KR101877834B1 (en) * 2017-04-27 2018-07-12 주식회사 다산제약 Novel salts of mirabegron and manufacturing method thereof
KR20170088783A (en) * 2017-07-07 2017-08-02 지엘팜텍주식회사 Wetgranulation composition containing mirabegron
KR101937713B1 (en) 2017-07-14 2019-01-14 주식회사 대웅제약 Pharmaceutical formulation and preparation method for the same
WO2019013583A2 (en) * 2017-07-14 2019-01-17 주식회사 대웅제약 Pharmaceutical preparation and preparation method therefor
US10478399B2 (en) * 2017-10-12 2019-11-19 Synthon B.V. Modified release tablet composition comprising mirabegron
KR102018495B1 (en) * 2018-03-13 2019-09-05 충북대학교 산학협력단 Sustained-release bilayer tablets for the treatment of overactive bladder And method for manufacturing the same
KR102371567B1 (en) * 2018-04-06 2022-03-07 한미약품 주식회사 Controlled Release Pharmaceutical Composition comprising Mirabegron
WO2020097328A1 (en) * 2018-11-07 2020-05-14 Velicept Therapeutics, Inc Fixed dose pharmaceutical compositions for treating overactive bladder and related conditions
KR102062791B1 (en) * 2019-02-26 2020-01-06 신일제약 주식회사 Pharmaceutical formulation for controlled release containing mirabegron or pharmaceutically acceptable salts thereof as an active ingredient
US20210353546A1 (en) * 2020-05-12 2021-11-18 Jubilant Pharma Holdings Inc. Dual release pharmaceutical compositions comprising the combination of a beta-3 adrenoreceptor agonist and a muscarinic receptor antagonist
EP4159199A1 (en) 2021-09-29 2023-04-05 Lotus Pharmaceutical Co., Ltd. Combined formulation of mirabegron and solifenacin

Family Cites Families (10)

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Publication number Priority date Publication date Assignee Title
NO2005012I1 (en) 1994-12-28 2005-06-06 Debio Rech Pharma Sa Triptorelin and pharmaceutically acceptable salts thereof
ES2169558T3 (en) * 1997-10-03 2002-07-01 Warner Lambert Co COMPRESSED NITROGLYCERINE PILL AND METHOD FOR PRODUCTION.
ID23989A (en) 1997-10-17 2000-06-14 Yamanouchi Pharma Co Ltd THE AMIDA DOWNS OR THE SALT
US7342117B2 (en) 2001-10-30 2008-03-11 Astellas Pharma Inc. α-form or β-form crystal of acetanilide derivative
JP3815496B2 (en) 2002-11-07 2006-08-30 アステラス製薬株式会社 Overactive bladder therapeutic agent containing an anilide acetate derivative as an active ingredient
CA2704298C (en) * 2007-11-02 2015-07-21 Astellas Pharma Inc. Pharmaceutical composition for treating overactive bladder
TWI478712B (en) * 2008-09-30 2015-04-01 Astellas Pharma Inc Pharmaceutical composition for modified release
SI2394648T1 (en) 2009-02-04 2017-02-28 Astellas Pharma Inc. Pharmaceutical composition for oral administration
KR20130135239A (en) * 2010-08-03 2013-12-10 앨씨알엑스, 인크. Combinations of beta-3 adrenergic receptor agonists and muscarinic receptor antagonists for treating overactive bladder
TWI612975B (en) * 2012-03-02 2018-02-01 安斯泰來製藥股份有限公司 Quickly disintegrating tablet

Also Published As

Publication number Publication date
PH12015500313A1 (en) 2015-04-20
IL237423A0 (en) 2015-04-30
SG11201501415RA (en) 2015-05-28
TW201424772A (en) 2014-07-01
EP2891493A1 (en) 2015-07-08
ZA201501977B (en) 2016-07-27
WO2014034860A1 (en) 2014-03-06
CN104602693A (en) 2015-05-06
EP2891493A4 (en) 2016-05-18
US20150306090A1 (en) 2015-10-29
HK1208801A1 (en) 2016-03-18
KR20150045500A (en) 2015-04-28
EA201590449A1 (en) 2015-06-30
CA2883270A1 (en) 2014-03-06
AU2013309922A1 (en) 2015-04-09
JPWO2014034860A1 (en) 2016-08-08
MX2015002633A (en) 2015-06-24

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]
B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]